Tell Congress: Stand up for patients, not drug companies!
- by: Consumers Union
- recipient: Your U.S. Senators
In the coming days, the Senate will make one of its most important decisions about your family's health by voting on a measure to strengthen our nation's prescription drug safety laws.
But this bill is in danger of being weakened. The Senate must hear right now from real people like you who want the safest and most effective medicines, rather than drug company lobbyists who prefer the status quo that has let Vioxx, Paxil and many other dangerous prescription drugs on the market.
Please take a moment to sign this petition to tell your Senators that their vote for drug safety is important to you. And ask them to strengthen S 1082, the Food and Drug Administration Revitalization Act, to ensure the safety of our medications.
Don't let drug companies put our health at risk. Tell your lawmakers that you want a strong, comprehensive bill that will restore our nation's drug safety system to the gold standard it should be.
UPDATE: The Senate could vote any day now on S. 1082 - please sign to send your message today!
But this bill is in danger of being weakened. The Senate must hear right now from real people like you who want the safest and most effective medicines, rather than drug company lobbyists who prefer the status quo that has let Vioxx, Paxil and many other dangerous prescription drugs on the market.
Please take a moment to sign this petition to tell your Senators that their vote for drug safety is important to you. And ask them to strengthen S 1082, the Food and Drug Administration Revitalization Act, to ensure the safety of our medications.
Don't let drug companies put our health at risk. Tell your lawmakers that you want a strong, comprehensive bill that will restore our nation's drug safety system to the gold standard it should be.
UPDATE: The Senate could vote any day now on S. 1082 - please sign to send your message today!
Strengthen S.1082 when it gets to the Senate floor for a vote!
Dear Senator,
You will soon be voting on an extremely important issue to me and my family: S 1082, the Food and Drug Administration Revitalization Act. I urge you to do all you can to ensure the drug safety provisions incorporated into this measure are as strong and effective as possible, including offering and supporting amendments to improve the bill.
It has been more than two years since it was revealed the makers of Vioxx and Paxil knew about the deadly side effects of their drugs, but failed to reveal that information to the public. Yet today, the law still allows drug makers to keep studies from the public that could alert doctors and patients to dangerous side effects.
S.1082 would address this and other major gaps in our drug safety process, which many of the nation's top researchers, doctors and consumer groups have said is broken. In fact, the Institute of Medicine issued a report highly critical of the FDA's ability to perform its drug safety mission. Some of the IOM's recommendations are included in this legislation, but not all.
Please take this once-in-a-lifetime opportunity to show the public that Congress takes seriously its commitment to getting safe and effective drugs on the market. None of these measures will slow the flow of important, life-saving drugs to patients. Rather, a strong bill will help ensure that the medicines my family takes are as safe and effective as possible.
I urge you to push for the following improvements in the bill:
1. Ensure that clinical trial registration and publication of results applies to all Phase II, III and IV trials (Phase II trials are partially exempted in the bill), and require publication of results within a set period of time, ideally no more than a year after completion of a trial, to avoid foot-dragging by industry. Also, all clinical trials completed before passage of the bill should be made available to the public, so we can know the full pros and cons of a drug.
2. A higher level of civil monetary fines, and public listing, of those companies that do not comply with FDA drug safety requirements. Pharmaceutical companies make millions in profits on FDA-approved drugs, and small fines likely will not serve as a deterrent.
3. More resources for the FDA so the agency can do its job. Increased resources will help ensure all drug advertising is reviewed, reports of safety problems analyzed, patients in clinical trials are protected from unnecessary dangers, follow-up safety studies are conducted and FDA's ancient computer system modernized.
4. Openness and public participation in the negotiations between the drug companies and the FDA on safety disputes, and development of risk evaluation and management strategies. It is important that safety disputes not be conducted behind closed doors, and that the public quickly be made aware of serious safety risks when they arise.
5. Require that drugs commonly used off-label are studied for safety of those uses. This will do nothing to discourage doctors from off-label prescribing, but rather, will put science behind these decisions.
6. Create a system where FDA doctors and scientists can express their concerns about drug safety without fear of retaliation.
I ask that you work to strengthen S. 1082 by supporting the improvements listed above.
Thank you for your consideration, and I look forward to your support and response.
Sincerely,
[Your Name]
[Your Address]
[City, State ZIP]
Sign PetitionSign PetitionDear Senator,
You will soon be voting on an extremely important issue to me and my family: S 1082, the Food and Drug Administration Revitalization Act. I urge you to do all you can to ensure the drug safety provisions incorporated into this measure are as strong and effective as possible, including offering and supporting amendments to improve the bill.
It has been more than two years since it was revealed the makers of Vioxx and Paxil knew about the deadly side effects of their drugs, but failed to reveal that information to the public. Yet today, the law still allows drug makers to keep studies from the public that could alert doctors and patients to dangerous side effects.
S.1082 would address this and other major gaps in our drug safety process, which many of the nation's top researchers, doctors and consumer groups have said is broken. In fact, the Institute of Medicine issued a report highly critical of the FDA's ability to perform its drug safety mission. Some of the IOM's recommendations are included in this legislation, but not all.
Please take this once-in-a-lifetime opportunity to show the public that Congress takes seriously its commitment to getting safe and effective drugs on the market. None of these measures will slow the flow of important, life-saving drugs to patients. Rather, a strong bill will help ensure that the medicines my family takes are as safe and effective as possible.
I urge you to push for the following improvements in the bill:
1. Ensure that clinical trial registration and publication of results applies to all Phase II, III and IV trials (Phase II trials are partially exempted in the bill), and require publication of results within a set period of time, ideally no more than a year after completion of a trial, to avoid foot-dragging by industry. Also, all clinical trials completed before passage of the bill should be made available to the public, so we can know the full pros and cons of a drug.
2. A higher level of civil monetary fines, and public listing, of those companies that do not comply with FDA drug safety requirements. Pharmaceutical companies make millions in profits on FDA-approved drugs, and small fines likely will not serve as a deterrent.
3. More resources for the FDA so the agency can do its job. Increased resources will help ensure all drug advertising is reviewed, reports of safety problems analyzed, patients in clinical trials are protected from unnecessary dangers, follow-up safety studies are conducted and FDA's ancient computer system modernized.
4. Openness and public participation in the negotiations between the drug companies and the FDA on safety disputes, and development of risk evaluation and management strategies. It is important that safety disputes not be conducted behind closed doors, and that the public quickly be made aware of serious safety risks when they arise.
5. Require that drugs commonly used off-label are studied for safety of those uses. This will do nothing to discourage doctors from off-label prescribing, but rather, will put science behind these decisions.
6. Create a system where FDA doctors and scientists can express their concerns about drug safety without fear of retaliation.
I ask that you work to strengthen S. 1082 by supporting the improvements listed above.
Thank you for your consideration, and I look forward to your support and response.
Sincerely,
[Your Name]
[Your Address]
[City, State ZIP]
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